Multicentric Single Arm Phase II Study Evaluating the Efficacy of Association of Tucatinib, Capecitabine and Intra-CSF Trastuzumab in HER2 Amplified Breast Cancer Patients With Leptomeningeal Metastases (ETIC-LM)

NCT05800275 Phase 2 RECRUITING

The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.

Details

Lead sponsor	UNICANCER
Phase	Phase 2
Status	RECRUITING
Enrolment	30
Start date	2023-12-18
Completion	2027-06

Conditions

• Leptomeningeal Metastasis
• Leptomeningeal Disease
• HER2-positive Metastatic Breast Cancer

Interventions

• Tucatinib Oral Tablet
• Capecitabine tablets
• Trastuzumab Injection

Primary outcomes

• overall survival rate at 12 months — 12 months
  12-month overall survival will be defined as the proportion of patients alive 12 months after treatment initiation.

Countries

France